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Duct Cholecystectomy: Major Laparoscopic
Duct Cholecystectomy: Major Laparoscopic
I...
-I....::'
Objective
The authors provide the results of follow-up evaluation after combined surgical and
radiologic management of 89 patients with major bile duct injuries during laparoscopic
cholecystectomy.
459
460
showed a success rate of 92%. All failures were managed successfully by either surgical
reconstruction or balloon dilatation.
Conclusions
Major bile duct injuries can be managed successfully by combined surgical and radiologic
techniques. This series provides, for the first time, significant follow-up on a large number
of patients with overall success rates of 64% after balloon dilatation and 92% after surgical
reconstruction. The combination of surgery and balloon dilatation resulted in a successful
outcome in 100% of patients treated.
In seven patients (7.9%), the injury occurred during laparoscopic cholecystectomy at The Johns Hopkins Hospital,
whereas the remaining 82 patients were referred after
injury at an outside hospital. The initial management of
all the patients referred with a bile duct injury consisted
of a percutaneous transhepatic cholangiogram and placement of percutaneous biliary catheters. In those patients
with injuries at or near the hepatic bifurcation, both the
right and left hepatic ductal systems were accessed with
transhepatic catheters. In patients with ongoing biliary
leaks, percutaneous drainage of bile collections or ascites
was also performed as indicated. It is our practice in such
patients to control the biliary leak and associated sepsis
and then allow a period for resolution of the associated
inflammation. In many cases, after control of the bile
leak, the patient was discharged to home and returned for
definitive repair at a later date.
In those patients in whom biliary-enteric continuity was
intact and percutaneous dilatation and stenting was an
option, the decision to pursue this alternative versus surgical repair was based on the clinical assessment of the
surgeon and interventional radiologist. If the option of
percutaneous dilatation and stenting was chosen, the need
for repeat dilatation, the length of stenting, and the decision to abandon this technique in favor of surgical reconstruction again was based on the clinical judgment of the
treating surgeon and radiologist.
Surgical management consisted of a Roux-en-Y hepaticojejunostomy. All procedures were performed electively with one to three biliary catheters placed before
surgery to facilitate the operative procedure.24 After identification and mobilization of the proximal hepatic duct,
the preoperative catheters were exchanged for larger soft
silastic stents. A Roux-en-Y limb of jejunum, 50 to 60
cm in length, was created, and an end-to-side hepaticojejunostomy was performed with the stents placed through
the anastomosis.
The anastomoses were performed routinely with interrupted absorbable suture with the Roux limb placed in a
retrocolic position. The perianastomotic area was drained
with closed suction drains. In the immediate postoperative
period, the stents were left to external drainage. At postoperative day 4 or 5, a cholangiogram was performed,
461
35
25
30
20
25
15n
20
0
15
10
5
< 29
and if the study was satisfactory, the stents were internalized, and the patient's hospital course was completed as
directed by the surgical staff. The silastic stents were
changed routinely on an outpatient basis every 2 to 3
months. The length of postoperative stenting was determined by the treating surgeon based on the clinical scenario, the location of the injury, and the follow-up cholangiographic appearance. In most patients, a biliary Whitaker study25 and 2-week clinical trial with the stent
positioned above the anastomosis were completed before
stent removal.
A patient's treatment was considered complete at the
time of removal of all biliary stents. The length of followup was considered from the time of the patient's definitive
surgical or radiologic procedure. Follow-up evaluation
results were obtained by review of the patient's Johns
Hopkins Hospital and Outpatient Center medical records
and/or by personal telephone interview conducted during
October 1996. Outcome was assessed subjectively by history with symptoms of abdominal pain, fever, chills, and
jaundice being noted. The results of any diagnostic evaluation or therapeutic procedures performed after completion of the treatment were recorded and confirmed by
hospital records.
Patients' current status was rated subjectively as excellent if they had no symptoms attributable to their biliary
tract injury or reconstruction and rated good if mild symptoms, not requiring invasive investigation or treatment,
were present. Patients classified as either excellent or
good were considered to be a treatment success. Patients
were considered to be a treatment failure if a second
therapeutic procedure, either surgical or radiologic, was
necessary to treat ongoing symptoms or stricture recurrence. These definitions were consistent with an earlier
report from this institution.26
Statistical comparisons were made using Student's t
test and Fisher's exact test as appropriate. Actuarial suc-
30-39
40-49
50-59
60-69
>70
Age in Years
Figure 2. Age distrbution of patients with major bile duct injuries after
laparoscopic cholecystectomy.
cess rates were analyzed by the Mantel-Cox technique. A
p value of <0.05 was considered statistically significant.
RESULTS
Patient Characteristics, Prior
Management, and Presentation
Eighty-nine patients with major bile duct injuries have
been treated at The Johns Hopkins Hospital since the
initial patient was referred in August 1990 (Fig. 1). Seventy-two patients (81%) were female. The average age
of the patients was 41.2 years (range, 22-78 years; Fig.
2). Eighty-two patients (92.9%) had undergone laparoscopic cholecystectomy at an outside hospital and were
referred with a presumed or confirmed bile duct injury
(Table 1). In 26 patients (31%), the bile duct injury had
been recognized at the time of laparoscopic cholecystec-
No. (%)
26 (31)
26 (100)
14 (54)
12 (46)
56 (69)
18 (32)
6 (33)
12 (67)
9 (16)
44 (54)
20 (45)
24 (55)
53 (65)
462
injury.
The interval from laparoscopic cholecystectomy to referral to The Johns Hopkins Hospital ranged from 1 day
to 48 months with a mean of 7.7 months for all 82 patients
referred. The interval was < 1 month in 35 patients (43%)
and longer than 12 months in 13 patients (16%). In 31
patients (38%), an ongoing biliary leak (bile ascites or
peritonitis, a biloma or abscess, or an external fistula)
was present at the time of referral. In 30 patients (37%),
obstructive jaundice was the primary reason for referral,
whereas in 18 patients (22%), cholangitis was the major
indication. All patients referred with cholangitis had undergone an attempt at biliary reconstruction before referral. In the remaining three patients, a biliary stent (two
percutaneous transhepatic and one endoscopic) had been
placed after a cholangiogram, which had showed a biliary
injury. These patients were referred without active cholangitis or jaundice for definitive management of the in-
jury.
Seven patients underwent biliary reconstruction after
laparoscopic cholecystectomy performed at Johns Hopkins. In five of these seven patients (71%), the injury was
recognized at the time of laparoscopic cholecystectomy,
and the patient was converted to an open procedure. In
four patients, reconstruction with a Roux-en-Y hepaticojejunostomy with intraoperative placement of transhepatic
silastic stents (one stent, three patients; two stents, one
patient) was performed. In the fifth patient, a primary endto-end ductal anastomosis over a T-tube was completed.
Jaundice developed in the sixth patient in the early postop-
erative period, who then underwent percutaneous transhepatic cholangiography, which showed complete obstruction of the common hepatic duct. A transhepatic biliary
catheter was placed, and definitive repair was performed
during the same hospitalization. The final patient presented with obstructive jaundice 3 months after a laparoscopic cholecystectomy performed for acute cholecystitis.
Her initial operative procedure and postoperative course
had been uncomplicated. At the time of her presentation,
she underwent a percutaneous transhepatic cholangiogram, and a Roux-en-Y hepaticojejunostomy was performed for a bile duct stricture.
Management
Percutaneous transhepatic cholangiography was performed and percutaneous biliary catheters were placed
shortly after admission in all patients referred with suspected bile duct injuries. In 31 patients (38% of patients
referred), an ongoing biliary leak was shown. In those
patients without prior external drainage of the leak, percutaneous drainage of bile ascites or a bile collection was
performed. In only one patient was early operation necessary to drain an infected bile collection.
There were two deaths in the series for an overall mortality of 2.2%. Both patients were older men (ages 62
and 72) who were septic with multisystem organ failure
secondary to ongoing biliary leaks at the time of transfer
to The Johns Hopkins Hospital. The first patient had undergone a hepaticojejunostomy and a second laparotomy
to repair an ongoing bile leak before referral. The second
patient had undergone two laparotomies for intra-abdominal sepsis due to a bile leak, but no biliary reconstruction
had been attempted. Both patients underwent successful
percutaneous transhepatic cholangiography and placement of biliary catheters, and the biliary leak appeared to
be controlled. No intra-abdominal collections were seen
on computed tomogram scan. Both patients died from
multisystem organ failure without a surgical procedure
being performed. In all other patients, the leak and associated biliary sepsis was controlled. Thirteen patients (45%)
presenting with a bile leak eventually were discharged
after referral and subsequently readmitted for definitive
surgical reconstruction at a mean of 4.7 weeks (median,
5 weeks; range, 2-6 weeks). There were no deaths in
any of the 87 patients undergoing definitive management
at The Johns Hopkins Hospital either by surgical reconstruction or percutaneous dilatation during the immediate
post-treatment period or throughout the follow-up period.
In 28 (32%) of the 87 surviving patients, percutaneous
dilatation and stenting was performed as the initial attempt at definitive management (Table 2). All 28 patients
had undergone a prior attempt at bile duct repair, therefore
representing 64% of patients referred with a prior biliary
[no. (%)]
Surgical
Reconstruction
(N = 59)
[no. (%)]
28* (100)
11 (39)
17 (61)
15 (25)
9 (60)
6 (40)
Dilatation
(N = 28)
Previous repair
End-to-end ductal
Biliary-enterc
Presenting symptoms
Jaundice
Biliary leak
Cholangitis
None
Recognized at laparoscopic
cholecystectomy
Level of obstruction
Bismuth 1
Bismuth 2
Bismuth 3
Bismuth 4
Bismuth 5
Isolated RHD
Use of stents (no.)
1
2
3
Dilatations (no.)
1
2
3+
11
8
8
1
(39)
(29)
(29)
(4)
21 (36)
21 (36)
10 (17)
2 (3)
5 (8)
6t (21)
12 (43)
6 (21)
3 (11)
1 (4)
3 (5)
20 (34)
21 (36)
7 (12)
3 (5)
5 (8)
15 (54)
1 1 (39)
2 (7)
20 (34)
36 (61)
3 (5)
18 (64)
8 (29)
2 (7)
463
Outcome
reconstruction. These prior repairs consisted of an endto-end duct repair in 11 patients (39%) and a hepaticojejunostomy in 17 patients (61%). Eleven (39%) of the 28
patients presented with obstructive jaundice, 8 patients
(29%) with a biliary leak, and 8 (29%) with episodes of
cholangitis. One patient was asymptomatic after percutaneous drainage at an outside hospital. The interval from
injury to referral ranged from 1 week to 40 months (mean,
7.8 months; median, 2 months). Twelve patients were
referred at 1 month or less after injury. The level of the
injury with respect to the confluence of the hepatic ducts,
as described by Bismuth,27 is listed in Table 2. The number of stents and the number of dilatations performed also
are included in Table 2.
In 59 (68%) of the surviving 87 patients, the initial
definitive management consisted of surgical biliary reconstruction. Only 15 (25%) of these patients had undergone
an attempt at repair before treatment at Johns Hopkins.
The previous repairs consisted of nine end-to-end ductal
464
Number
Outcome
Success
Excellent
Good
Failure
Predictors of outcome (no. of
failures/total patients)
Previous repair
End-to-end ductal
Hepaticojejunostomy
None
Presenting symptom
Jaundice
Biliary leak
Cholangitis
Bismuth class
1 and 2
3, 4, 5
RHD
Interval to referral
'1 month
>1 month
Balloon
Dilatation
Surgical
Reconstruction
25
52
16
12
4
9
(64%)t
(48%)t
(16%)
(36%)t
48
41
7
4
(92%)
(79%)
(13%)
(8%)
9/25
4/10
5/15
3/12
2/8
1/4
1/40**
1/9
6/8
2/7
3/21
2/27
0/9
3/16
6/811
1/20
2/27
1/5
7/11
2/14
1/16
3/36
patients) (Table 3). The actuarial success for surgical repair as an initial therapy is shown in Figure 3. The success
rate for surgical repair was significantly better than for
balloon dilatation (p < 0.002). The range of follow-up is
from 4 to 75 months with a mean follow-up of 33.4
months and a median follow-up of 29 months. There have
been four failures of surgical management occurring at
8, 13, 21, and 27 months. Factors potentially predicting
outcome are listed in Table 3. Three of the four failures
had undergone a repair before referral to Johns Hopkins.
The Bismuth classification was level 2 in one patient and
level 4 in two patients. The remaining patient had an
injury that was an isolated transected right hepatic duct
and had presented with a bile leak. Three of the four
failures were managed by percutaneous dilatation with
excellent or good results in all three patients with followup of 17, 22, and 39 months. The fourth patient underwent
a revision of his hepaticojejunostomy and has had an
excellent result at 22 months of follow-up.
The length of postoperative stenting was of intermediate length in two of the patients who did not respond to
surgical repair and long-term in the remaining two patients. The length of stenting was not significant as a
predictor of outcome.
As discussed above, all patients who failed their initial
management with either balloon dilatation or surgical reconstruction currently are considered a treatment success
after a second procedure. Therefore, of the 77 patients
who have completed therapy, including both primary
management and additional treatment for an unsuccessful
initial result, a successful outcome has been achieved in
100% of patients. In 28 patients who completed therapy
after balloon dilatation, performed as either initial therapy
or as therapy after a failed hepaticojejunostomy performed at this institution, an overall success rate of 68%
was seen (mean follow-up, 27.7 months; median followup, 22.5 months). Similarly, a total of 61 patients have
Surgical Repair
0.9 .
UM
C.
--
0.8
p<O.002
0.7 .
--
Balloon Dilatation
0.6 .
0.5 .
A
I Ij
24
1A
36
-2
AO
48
11,n
60
11,
Months
Figure 3. Actuarial success rate for surgical repair and balloon dilatation as the initial treatment for bile duct injuries after laparoscopic cholecystectomy. The difference is highly statistically significant (p < 0.002).
DISCUSSION
Since its introduction in the late 1980s, laparoscopic
cholecystectomy has gained widespread acceptance
among surgeons and the public and has essentially replaced open cholecystectomy as the treatment of choice
for symptomatic gallstones. Compared with open cholecystectomy, laparoscopic cholecystectomy is associated
with less postoperative pain, a shorter hospital stay, earlier
return to work, and a better cosmetic outcome.28 Unfortunately, compared to open cholecystectomy, laparoscopic
cholecystectomy appears to be associated with an increase
in the incidence of bile duct injuries. Before the introduction of laparoscopic cholecystectomy, the incidence of
major bile duct injury was considered to be 2 to 3 injuries
per 1000 procedures.13'2930 Roslyn et al.30 analyzed the
results of more than 42,000 open cholecystectomies performed in the United States in 1989 and found the incidence of bile duct injury to be 0.2%. In a review by
Strasberg et al.'3 of more than 25,500 open cholecystectomies reported in the literature since 1980, major bile duct
injury was reported in 0.3% of patients.
The incidence of bile duct injury during laparoscopic
cholecystectomy has varied from large single institution
series without a single biliary injury3l-34 to surveys encompassing thousands of patients from multiple hospitals with
the incidence of injury reported as high as 0.9%.4- 1035
The review by Strasberg et al.'3 of more than 124,000
laparoscopic cholecystectomies reported in the literature
found the incidence of major bile duct injury to be 0.5%.
It had been hoped, as most surgeons passed through the
"learning curve" of laparoscopic cholecystectomy, that
the incidence of injury would decline. Unfortunately, a
recent "steady-state" report of more than 10,000 cases at
U.S. military institutions by Wherry and colleagues'0 has
shown no significant improvement over the initial report
from the same institutions.9
As experience in the management of laparoscopic bile
duct injuries has been gained, the mechanisms of injury
have been established. Misidentification of anatomy appears to be the most common cause of laparoscopic bile
duct injury. The most common scenario, initially described by Davidoff et al." at Duke as the "classic"
injury, involves mistaking the common bile duct for the
cystic duct. The structure then is clipped and divided.
Further retraction of the gallbladder will lead to a second
higher injury with division of the common hepatic duct
465
466
467
with laparoscopic bile duct injuries undergoing both surgical reconstruction and nonoperative percutaneous balloon dilatation. These patients represent a heterogeneous
group of patients, including those in whom the injury
took place at our own institution, patients who were referred before any attempt at repair, and patients referred
after attempts at biliary reconstruction. In total, 54% of
the patients referred from outside hospitals had undergone
an attempt at repair before referral. Active ongoing biliary
leak was present in 38% and sepsis due to cholangitis
was present in 22% of patients at the time of referral to
our institution. The patients referred to our center with
injuries were all managed with combined radiologic and
surgical management. Preoperative imaging of the biliary
tree by way of the percutaneous transhepatic route and
placement of biliary stents were performed in all patients.
Subsequent management was based on the clinical scenario and cholangiographic appearance with patients selected accordingly for either primary management by radiologic balloon dilatation or surgical repair.
Follow-up to the present time was obtained by direct
patient contact in 86 of 87 surviving patients and ranged
from 4 to 75 months with a mean of 31.4 months and a
median of 28.5 months. Primary nonoperative management with balloon dilatation was associated with an overall success rate of 64%. In contrast, primary surgical management with hepaticojejunostomy was associated with a
success rate of 92%. Although this difference was statistically significant, we do not conclude that this study directly favors one treatment option over the other. Patients
undergoing balloon dilatation all had undergone a previous attempt at repair, and in a number of the cases, the
balloon dilatation option was aborted in favor of surgery
before completion of a full treatment course. Fortunately,
the 13 failures (9 dilatation failures and 4 surgical failures) were all salvaged by secondary management. Therefore, using combined surgical and radiologic management, 100% of patients have achieved a successful outcome at the time of this evaluation.
Although the follow-up in this series is substantial,
continued surveillance and follow-up will be necessary.
Pitt et al.37 in their analysis of factors influencing the
outcome after repair of postoperative bile duct strictures
in the prelaparoscopic era have reported that only 68%
of recurrent strictures will have developed by 3 years
after repair. If this analysis, derived from open cholecystectomy data, can be applied to the current series, the
long-term success rate of balloon dilatation would be approximately 50% and of surgical reconstruction would be
86%. These projected results are almost identical to those
reported previously from this institution from the open
cholecystectomy era. 26
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468
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Discussion
DR. WILLIAM C. MEYERS (Worcester, Massachusetts): Thank
you, Dr. Cameron, Dr. Copeland, Members, and Guests. I agree
with you, Dr. Cameron, that you've assembled the finest group
of gastrointestinal surgeonms in the country and the continent.